Thermo-sensitive in-situ gel pharmaceutical composition

An in-situ gel and composition technology, which is applied in the field of in-situ gel pharmaceutical compositions, can solve the problems of inability to form temperature-sensitive gels, high cost, and large dosage

Inactive Publication Date: 2011-07-20
PEKING UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although poloxamer has good biocompatibility, safety and non-irritating allergies, it is not biodegradable, and it is used in a large amount and the cost is high
CN101327183A discloses the preparation method of chitosan in situ gel medicament, but what this reference discloses is actually the preparation method of chitosan drug film, and its preparation temperature is 0~40 ℃, so it will not gel at physiological temperature , and it is well known to those skilled in the art that chitosan itself cannot form a thermosensitive gel at physiological temperature

Method used

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  • Thermo-sensitive in-situ gel pharmaceutical composition

Examples

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Effect test

Embodiment 1

[0020] Embodiment 1: Preparation of temperature-sensitive in-situ gel

[0021] According to 1.32% chitosan (deacetylation degree is 80%, molecular weight 800,000), 18% glucose phosphate, 1% cetirizine hydrochloride weight percentage, chitosan is dissolved in 0.1M hydrochloric acid Neutralize and stir evenly, then add cetirizine hydrochloride, stir to dissolve, add appropriate amount of Tween80, benzalkonium bromide, finally add glucose phosphate, stir evenly, filter, sterilize, can, and seal. Each gram of gel contains 10 mg of cetirizine hydrochloride. The gelation temperature was determined to be 34°C by the test tube inversion method.

Embodiment 2

[0022] Embodiment 2: Preparation of temperature-sensitive in-situ gel

[0023] By 1.32% chitosan (degree of deacetylation is 85%, molecular weight 400,000), 26% sorbitol phosphate, 3% cetirizine hydrochloride by weight percentage, chitosan is dissolved in 0.1M Add in hydrochloric acid and stir evenly, then add cetirizine hydrochloride, stir to dissolve, add appropriate amount of Ploumic F68, thimerosal, and finally add sorbitol phosphate, stir evenly, filter, sterilize, can, and seal. Each gram of gel contains 30 mg of cetirizine hydrochloride. The gelation temperature was determined to be 33°C by the test tube inversion method.

Embodiment 3

[0024] Embodiment 3: Preparation of temperature-sensitive in-situ gel

[0025]According to 1.32% chitosan (deacetylation degree is 82%, molecular weight 550,000), 21.5% fructose phosphate, 2% cetirizine hydrochloride by weight percentage, chitosan is dissolved in 0.1M hydrochloric acid and stir evenly, then add cetirizine hydrochloride, stir to dissolve, add appropriate amount of edetate disodium, ethylparaben, finally add fructose phosphate, stir evenly, filter, sterilize, can, seal Instantly. Each gram of gel contains 20mg of cetirizine hydrochloride. The gelation temperature was determined to be 34°C by the test tube inversion method.

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Abstract

The invention relates to an in-situ gel pharmaceutical composition, and in particular relates to a thermo-sensitive in-situ gel pharmaceutical composition, and a method for administering the pharmaceutical composition to treat and / or prevent diseases in mammals, particularly human beings. The pharmaceutical composition comprises drugs, chitosan, auxiliary gel matrix materials and pharmaceutically acceptable adjuvants. The pharmaceutical composition is superior in biocompatibility and biodegradability. The pharmaceutical composition provided by the invention has a simple preparation method, a transparent appearance and good stability, and is non-irritant and non-toxic to the mucosa.

Description

technical field [0001] The present invention relates to an in situ gel pharmaceutical composition, and a method for treating and / or preventing diseases in mammals, especially humans, using the pharmaceutical composition of the present invention. Background technique [0002] In-situ gel, also known as in-situ gel or instant gel, refers to a free-flowing liquid state at room temperature or storage conditions. After administration in a solution state, a phase transition occurs rapidly at the administration site to form a semi- A liquid formulation of a solid gel. Temperature-sensitive in-situ gels, whose gelation mechanism is in-situ gels formed by changes in ambient temperature. The system contains a temperature-sensitive polymer compound. After administration, the polymer solution forms a non-chemically cross-linked gel due to changes in internal and external temperatures. The gel system is simple to prepare, in a liquid state in vitro, with low viscosity, accurate dosage,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K47/36A61K47/26A61K47/28A61K47/34A61K47/40A61K47/24
Inventor 刘艳李馨儒陈星伟周艳霞
Owner PEKING UNIV
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